Ambulatory medical device and method for communication between medical devices

ABSTRACT

An ambulatory medical device and a method of communication between medical devices are disclosed. In one embodiment, the medical device includes a module for communication with at least a second medical device wherein the module for communication is adapted to be activated by a value of a physiological parameter of an animal. In one embodiment, the method of the present invention involves a first medical device and at least a second medical device wherein the communication between said medical devices is activated by a value of a physiological parameter of an animal.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application is a Continuation of application Ser. No. 11/832,421,filed Aug. 1, 2007, which is a Continuation of International ApplicationNo. PCT/EP2006/000663, filed on Jan. 26, 2006, which claims priority toEuropean Patent Application No. 05 002 074.2, filed on Feb. 2, 2005,which are incorporated in their entirety herein by reference.

BACKGROUND

The present invention relates devices for injecting, infusing,delivering, dispensing or administering substances, and to methods ofmaking and using such devices. More particularly, it relates to anambulatory medical device and a method of communication for orcommunicating between or among medical devices.

Ambulatory medical devices include devices for the treatment ofdiabetes, e.g. extra corporal insulin pumps and blood glucose measuringdevices such as hand held glucose meters. Insulin pumps allow a goodcontrol of blood glucose concentrations by continuously infusing a basicamount of insulin in a human body (basal insulin rate) and by allowingmanually controlled delivery of additional “meal bolus” insulinquantities thereby reflecting the insulin secretion by the pancreas.Furthermore, the development of continuous glucose sensors will allowmeasuring in vivo glucose concentrations over the whole day. Themeasured glucose date can be used to adjust the diabetes therapy toindividual needs.

To improve the treatment of medical conditions, including diabetes, itwould be helpful to provide a way to transfer data and/or communicateinformation between and/or among medical devices in a way that assuresoptimal quality and accuracy of the function of the devices, theinformation being communicated, and the exchange of the information.

SUMMARY

It is an object of the present invention to provide a medical system andmethod providing a controlled data transfer between medical devices.

In one embodiment, the present invention comprises a medical devicecomprising a module for communication with at least a second medicaldevice wherein the module for communication in the medical device isadapted to be activated by a value of a physiological parameter of ananimal.

In one embodiment, the medical device and/or devices comprise atelemetry system or feature for wireless communication, e.g. in onepreferred embodiment, a telemetry system for RF communication.

In some preferred embodiments, the medical device is selected from thegroup consisting of a remote control, a PDA, an analyte measuringdevice, e.g., a glucose measuring device such as a hand held glucosemeter, a strip based or strip type glucose meter, or combinationsthereof.

In some embodiments, the physiological parameter may be selected fromthe group consisting of an analyte concentration, a physiologicalcharacteristic like conductivity of an animal, a physiological vitalsign such as heart or breath rate, temperature, movement, air- orstructure-borne sound, ECG (electrocardiogram), etc. In one preferredembodiment of the present invention, the analyte concentration is ablood glucose concentration.

In some preferred embodiments, the medical device of the presentinvention comprises an electrochemical or photometric module formeasuring blood glucose. Suitable medical devices are include stripbased glucose meters such as the meter known as the AccuChek Compact.

In one embodiment, the present invention relates to and/or comprises asystem of medical devices. The system comprises a first medical deviceof the present invention as described above and at least a secondmedical device capable of communicating with the first medical device.

In one preferred embodiment, the second medical device may be selectedfrom the group consisting of an extra corporal infusion pump, animplantable infusion pump, a pacesetter, an analyte or vital signsensor, a continuous analyte or vital sign sensor, and a continuousglucose sensor.

In another preferred embodiment, the first medical device and the atleast second medical device comprise a telemetry system for wirelesscommunication, in some preferred embodiments, a telemetry system for RFcommunication.

In another aspect, the present invention relates to or comprises amethod of communication between a first medical device and at least asecond medical device wherein the communication between said medicaldevices is enabled and/or activated by a value of a physiologicalparameter of an animal. In a preferred embodiment, the communicationbetween the at least two medical devices is enabled and/or activated fora predetermined time. The time duration can be fixed, random, dependenton the physiological parameter enabling and/or activating thecommunication, or dependent on other physiological parameters of theanimal body.

In some preferred embodiments, the physiological parameter may beselected from the group consisting of an analyte concentration, aphysiological characteristic like conductivity of an animal, aphysiological vital sign like heart or breath rate, temperature,movement, air- or structure-borne sound, ECG (electrocardiogram), etc.In some preferred embodiments, the analyte concentration is a bloodglucose concentration.

In one preferred embodiment, the activation of communication between themedical devices is performed on the first medical device by a value ofthe physiological parameter.

In some preferred embodiments, the first medical device may be selectedfrom the group consisting of a remote control, a PDA, an analytemeasuring device, a glucose measuring device, and a strip based glucosemeter. The second medical device may be selected from the groupconsisting of an extra corporal infusion pump, an implantable infusionpump, a pacesetter, an analyte sensor, a continuous analyte sensor, anda continuous glucose sensor.

In one preferred embodiment, the communication between the medicaldevices is a wireless communication, e.g., a RF communication. In otherpreferred embodiments, other suitable forms or methods of communicatinginformation, sensed parameters, data, commands, etc. may be used.

In one preferred embodiment, the first medical device receives data orinformation from the second medical device, and in another preferredembodiment, the first medical device sends commands to the secondmedical device controlling at least partially the function or operationof the second medical device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts one exemplary embodiment of the present invention,including arrows depicting the communication and/or flow of informationto and from components.

FIG. 2 depicts another exemplary embodiment of the present invention,including arrows depicting the flow of information to and fromcomponents.

FIG. 3 depicts another exemplary embodiment in accordance with thepresent invention, including arrows depicting the communication amongcomponents.

FIG. 4 depicts another exemplary embodiment of the present invention,including arrows depicting the flow of information to and fromcomponents.

FIG. 5 depicts an exemplary embodiment of a component in accordance withthe present invention.

DETAILED DESCRIPTION

With regard to fastening, mounting, attaching or connecting componentsof the present invention, unless specifically described as otherwise,conventional mechanical fasteners and methods may be used. Otherappropriate fastening or attachment methods include adhesives, weldingand soldering, the latter particularly with regard to the electronicsassociated with the invention, if any. Suitable electrical componentsand circuitry, wires, wireless components, chips, boards,microprocessors, receivers, transmitters, inputs, outputs, displays,control components, etc. may be used. Generally, unless otherwiseindicated, the materials used in the invention and/or its components maybe selected from appropriate materials such as metal, metallic alloys,ceramics, plastics, etc.

In one aspect, the present invention relates to a method for controllingand/or enabling communication between medical devices, such as medicalsensory devices such as continuous glucose sensors and/or therapeuticdevices such as insulin pumps and/or diagnostic medical devices such asglucose meters.

For example, referring to FIG. 1, in one exemplary system 2 inaccordance with the present invention, the communication between acontinuous glucose sensor 4 applied to a human body and a blood glucosemeter 6 can only be established when a blood glucose measurement hasbeen made in the blood glucose meter 6. The generation of the bloodglucose value in the blood glucose meter 6 enables and/or activatescommunication, represented at arrow A, between the two devices for aspecified time limit. During the time window data can be transferredfrom the sensor 4 to the glucose meter 6 and/or commands from theglucose meter 6 can be sent to the sensor 4. After expiration of a timelimit, communication between the two devices is deactivated. Toestablish a further or subsequent communication, the communication linkbetween the two devices has to be activated by generating a furtherblood glucose value in the glucose meter 6.

The term “generation of a value” as it is used herein encompasses anymethod or procedure for the determination of physiological parameterssuch as methods for the measurement of analyte values, e.g., bloodglucose values. Suitable methods for the determination of blood glucosevalues include electrochemical methods, photometric methods and otherswhich are known to a person skilled in the art.

The dependence of the communication link between medical devices on anactual analyte value ensures the quality of the data transmitted fromthe medical sensory device and/or medical therapeutical device to themedical diagnostic device.

The data transferred from the sensor 4 to the diagnostic device, e.g.,the meter 6, can be stored on the diagnostic device and be transferred,as represented by arrow B to a third device 8 such as a PDA or acomputer, for further processing and/or analysis. The data can beanalyzed and/or processed by suitable software and used, for example,for bolus recommendation or adjustment of basal insulin rates forpatients using an extra- or intra corporal insulin pump. Thecommunication link between the diagnostic device 6 and a third device 8does not necessarily need activation by generation of a blood glucosevalue in the diagnostic device 6.

Referring to FIG. 2, in one preferred embodiment, the present inventionrelates to a method of communication between a diagnostic medical device10, e.g., a blood glucose meter, and an infusion pump 12, e.g., an extracorporal insulin pump. In this embodiment, the diagnostic medical device10 is used as or functions as a remote control to control the functionof the infusion pump 12. After a blood glucose value has been generatedin the blood glucose meter 10 a communication link, represented by arrowC, between meter 10 and pump 12 is enabled and/or activated for adefined time and commands can be transferred from the remote control,i.e. the glucose meter, to the pump 12. It is also possible to transferdata stored on the pump 12 to the diagnostic device 10 during thecommunication time window.

With further reference to FIG. 2, in some embodiments comprising aremote controller 14 for the infusion pump 12, the remote controller 14may not comprise a feature or device for measuring blood glucoseconcentration. In such embodiments, the communication, represented byarrow C′, between pump 12 and remote control 14 is activated by enteringa current blood glucose value measured in a blood glucose meter in theremote control 14. The value may be entered using inputs of the remotecontrol 14 or can be transferred via a wireless or wired connection tothe glucose meter 10. After the blood glucose value has been entered inthe remote control 14, a communication link between remote control 14and infusion pump 12 is established, preferably for a predetermined timespan. After expiration of the time span, the communication isinterrupted and no data exchange between the two devices is anymorepossible. A further round of communication needs a new activation of thecommunication by entering a new, current blood glucose value in theremote control 14. The term remote control or controller as used hereinencompasses PDA's, smart phones, pump specific remote controllers, etc.

The data transfer between the medical devices can be performed usingknown and/or available technologies, and may comprise wired and/orwireless components, connections and/or communications. Thesetechnologies are known to a person skilled in the art. In one preferredembodiment, communication may be provided RF communication. In someembodiments, the data transfer between the devices can be encrypted toensure that non-authorized third parties do not gain access to personaldata of patients. Any suitable method of encrypting data, includingthose known to a person skilled in the art, may be used. In somepreferred embodiments, the communication between the medical devices maybe activated by a manipulation of or on the second medical device, e.g.insulin pump 12, such as pressing a button or lever, inserting abattery, using the touch screen, shaking, bumping or squeezing or thelike.

Referring to FIG. 3, in one preferred embodiment, the present inventioncomprises a system 18 of medical devices comprising a continuous glucosesensor device 20 which is placed on a human body to measure glucosevalue in interstitial fluid and a glucose meter 22. The sensor device 20comprises an electrochemical glucose sensor measuring the glucoseconcentration in the interstitial tissue in a predetermined manner. Thesensor device 20 further comprises an extra-corporal part 24 including asuitable processor or computer 26 for controlling the sensor 20, asuitable memory 28 for storing measured glucose values and a telemetrysystem or module 30 for transmitting the data to the glucose meter 22,e.g., a strip-based glucose meter. The glucose values stored on thesensor device 20 may then transferred to a glucose meter 22 via thetelemetry system 30 (as represented by arrows D and D′).

The communication between the devices, i.e. the wireless link, isestablished and/or activated by measuring the glucose concentration in ablood sample of a patient using the glucose meter 22. When a strip-basedglucose meter is used, the patient inserts a strip in the glucose meterand puts a droplet of blood on the strip. The glucose meter 22 measuresand indicates the blood glucose value, e.g., on an associated display.After measurement of the blood glucose value, the communication link canthen be activated/established either by, for example, pressing an inputon the glucose meter 22, e.g. an activation button, or by a directelectronic link to the processor 26 controlling the glucose telemetrysystem 30 such that the completion of the blood glucose measurementautomatically activates the wireless link between the devices.

The communication link is then established and a data transfer betweenthe medical devices is possible and/or occurs for a defined time span.After expiration of the defined time span the communication link isdeactivated and no further data/commands can be transmitted between themedical devices. A new blood glucose measurement in the glucose meter 22is then necessary to open a new wireless link between the medicaldevices.

In a further aspect, the present invention relates to a method of dataprocessing or data use, wherein the data processing or data use is onlypossible and/or only occurs after activation by a value of aphysiological parameter. The method is may be used for the processing ofmedical data such as data measured by a sensor applied on a human body.

Referring to FIG. 4, in one preferred embodiment, the method inaccordance with the present invention may be used for the processing ofmedical data sensed or measured by a sensor device 34 applied on a humanbeing, e.g., a continuous glucose sensor. The data is then transferred,as shown by arrow E, to a diagnostic medical device 36, e.g., a bloodglucose meter.

The data may be transferred via a wireless link from the sensor device34 to the diagnostic device 36. In this case, each of the at least twomedical devices comprises a telemetry system 38 for wirelesscommunication. The wireless communication can be bidirectional orunidirectional.

In some preferred embodiments, there is a permanent communication linkbetween said two medical devices, but the data stored in a memory 39 ofthe medical sensor device 34 and transferred to the diagnostic device 36can only be further processed on the diagnostic device 36 after theprocessing has been activated by a value of a physiological parameter.After activation by a value of a physiological parameter, preferably ablood glucose value, the data stored in the memory 39 of the diagnosticdevice 36 can be processed or used. For example, data are transferredfrom a continuous glucose sensor 34 to a glucose meter 36 and stored inthe memory of the glucose meter. The further processing of these data isthen only possible after activation of the processing by a value of aphysiological parameter, e.g., a blood glucose value. In one preferredembodiment, the processing of the data is only possible for a limitedtime span after activation by a value of a physiological parameter. Whenthe defined time span for data processing has lapsed, no further dataprocessing is possible without a new activation by a value of aphysiological parameter.

Referring to FIG. 5, in a further aspect the present invention maycomprise a medical device 40 comprising a module, feature or component42 for data processing which is adapted to be activated by a value of aphysiological parameter. The module 42 comprises a suitablemicroprocessor or computer with a memory for storing data. In somepreferred embodiments, the medical device 40 is a blood glucose meter.The processing of data stored in the memory of the blood glucose meter40 may be activated either by pressing an input associated with theglucose meter 40 (e.g., an activation button or switch) or by a directelectronic link to the hardware, firmware and/or software of the dataprocessing module 42 such that the completion of the blood glucosemeasurement automatically activates data processing. The terms “dataprocessing” or “data use” as they are used herein refer to anymanipulation of data and comprise analysis of data, presentation ofdata, communication of date, interpretation of data, indication of data,etc.

Embodiments of the present invention, including preferred embodiments,have been presented for the purpose of illustration and description.They are not intended to be exhaustive or to limit the invention to theprecise forms and steps disclosed. The embodiments were chosen anddescribed to provide the best illustration of the principles of theinvention and the practical application thereof, and to enable one ofordinary skill in the art to utilize the invention in variousembodiments and with various modifications as are suited to theparticular use contemplated. All such modifications and variations arewithin the scope of the invention as determined by the appended claimswhen interpreted in accordance with the breadth they are fairly,legally, and equitably entitled.

1. A system of medical devices comprising: a glucose measuring device configured to generate a blood glucose value based upon a physiological parameter representative of the blood glucose concentration of an animal; and a continuous glucose sensor, said glucose measuring device including a communication module configured to establish a wireless communication link enabling communication between said glucose measuring device and said continuous glucose sensor, the communication module further being configured, in response to completion of the generation of the blood glucose value, to determine a defined length of a time span for the communication link to be established, the defined length of the time span being determined using a value of the physiological parameter of the animal obtained by said glucose measuring device from said continuous glucose sensor during a previous communication between said glucose measuring device and said continuous glucose sensor; the communication module further being configured, following determination of the time span, to automatically activate for the defined time span from a deactivated state the wireless communication link, the communication module of the glucose measuring device being configured that after expiration of the defined time span the communication link between the glucose measuring device and the continuous glucose sensor is deactivated, said glucose measuring device being configured to send information to said continuous glucose sensor during the defined time span, and said continuous glucose sensor being configured to process the information received from said glucose measuring device.
 2. The system of claim 1 in which said continuous glucose sensor is configured to process the information during the defined time span.
 3. The system of claim 1 in which the communication module is configured to automatically deactivate the communication link upon expiration of the predetermined defined time span.
 4. The system of claim 1 in which the value of a the physiological parameter of the animal is the blood glucose value of the animal.
 5. The system of claim 1 in which the information includes a command from the glucose measuring device to at least partially control the continuous glucose sensor.
 6. The system of claim 5 in which the command from said glucose measuring device is to automatically activate processing of the information by said continuous glucose sensor based on transmitting the blood glucose value to said continuous glucose sensor.
 7. The system of claim 1 in which said continuous glucose sensor is configured to send data to said glucose measuring device during the defined time span, and said glucose measuring device is configured to process the data received from said continuous glucose sensor.
 8. The system of claim 7 in which said glucose measuring device is configured to process the data during the defined time span.
 9. A method of communicating between a glucose measuring device and a continuous glucose sensor, the glucose measuring device including a communication module configured to activate from a deactivated state a wireless communication link enabling communication between the glucose measuring device and the continuous glucose sensor, comprising: transmitting from the continuous glucose sensor to the glucose measuring device a first physiological parameter representative of the glucose value of an animal; using the first physiological parameter, determining a defined time span for the wireless communication link to be established; using the glucose measuring device, generating a blood glucose value based upon a second physiological parameter representative of the blood glucose concentration of the an animal; in response to the completion of the generation of the blood glucose value, automatically activating the communication link for the defined time span; during the predetermined defined time span, transmitting information from the glucose measuring device to the continuous glucose sensor; processing the information using the continuous glucose sensor; and upon expiration of the defined time span, automatically deactivating the communication link.
 10. The method of claim 9 in which said processing comprises the continuous glucose sensor processing the information during the defined time span.
 11. The method of claim 9 in which said deactivating comprises the communication module deactivating the wireless link between the glucose measuring device and the continuous glucose sensor upon expiration of the defined time span.
 12. The method of claim 9 in which the information includes a command from the glucose measuring device to at least partially control the continuous glucose sensor.
 13. The method of claim 12 in which the command from the glucose measuring device is to automatically activate processing of the information by the continuous glucose sensor based on transmitting the blood glucose value to the continuous glucose sensor.
 14. The method of claim 9 and further including sending data from the continuous glucose sensor to the glucose measuring device during the defined time span and processing the data using the glucose measuring device.
 15. The method of claim 14 in which said processing the data comprises the glucose measuring device processing the data during the defined time span. 